The Lack of Objectivity in Quality Management

ICH Q9(r1) can be reviewed as a revision that addresses long-standing issues of subjectivity in risk management. Subjectivity is a widespread problem throughout the quality sphere, posing significant challenges because it introduces personal biases, emotions, and opinions into decision-making processes that should ideally be driven by objective data and facts.

Inconsistent Decision-Making: Subjective decision-making can lead to inconsistencies because different individuals may have varying opinions and biases. This inconsistency can result in unpredictable outcomes and make it challenging to establish standardized processes. For example, one manager might prioritize customer satisfaction based on personal experiences, while another might focus on cost-cutting, leading to conflicting strategies within the same organization.
Bias and Emotional Influence: Subjectivity often involves emotional influence, which can cloud judgment and lead to decisions not in the organization’s best interest. For instance, a business owner might make decisions based on a personal attachment to a product or service rather than its market performance or profitability. This emotional bias can prevent the business from making necessary changes or investments, ultimately harming its growth and sustainability.
Risk Management Issues: In risk assessments, subjectivity can significantly impact the identification and evaluation of risks. Subjective assessments may overlook critical risks or overemphasize less significant ones, leading to inadequate risk management strategies. Objective, data-driven risk assessments are essential to accurately identify and mitigate potential threats to the business. See ICHQ9(r1).
Difficulty in Measuring Performance: Subjective criteria are often more complicated to quantify and measure, making it challenging to track performance and progress accurately. Objective metrics, such as key performance indicators (KPIs), provide clear, measurable data that can be used to assess the effectiveness of business processes and make informed decisions.
Potential for Misalignment: Subjective decision-making can lead to misalignment between business goals and outcomes. For example, if subjective opinions drive project management decisions, the project may deviate from its original scope, timeline, or budget, resulting in unmet objectives and dissatisfied stakeholders.
Impact on Team Dynamics: Subjectivity can also affect team dynamics and morale. Decisions perceived as biased or unfair can lead to dissatisfaction and conflict among team members. Objective decision-making, based on transparent criteria and data, helps build trust and ensures that all team members are aligned with the business’s goals.

Every organization I’ve been in has a huge problem with subjectivity, and I’m confident in asserting none of us are doing enough to deal with the lack of objectivity, and we mostly rely on our intuition instead of on objective guidelines that will create unambiguous, holistic, and
universally usable models.

Understand the Decisions We Make

Every day, we make many decisions, sometimes without even noticing it. These decisions fall into four categories:

Acceptances: It is a binary choice between accepting or rejecting;
Choices: Opting for a subset from a group of alternatives;
Constructions: Creating an ideal solution given accessible resources;
Evaluations: Here, commitments back up the statements of worth to act

These decisions can be simple or complex, with manifold criteria and several perspectives. Decision-making is the process of choosing an option among manifold alternatives.

The Fallacy of Expert Immunity is a Major Source of Subjectivity

There is a widely incorrect belief that experts are impartial and immune to biases. However, the truth is that no one is immune to bias, not even experts. In many ways, experts are more susceptible to certain biases. The very making of expertise creates and underpins many of the biases. For example, experience and training make experts engage in more selective attention, use chunking and schemas (typical activities and their sequence), and rely on heuristics and expectations arising from past base rate experiences, utilizing a whole range of top-down cognitive processes that create a priori assumptions and expectations.

These cognitive processes often enable experts to make quick and accurate decisions. However, these mechanisms also create bias that can lead them in the wrong direction. Regardless of the utilities (and vulnerability) of such cognitive processing in experts, they do not make experts immune from bias, and indeed, expertise and experience may actually increase (or even cause) certain biases. Experts across domains are subject to cognitive vulnerabilities.

Even when experts are made aware of and acknowledge their biases, they nevertheless think they can overcome them by mere willpower. This is the illusion of control. Combating and countering these biases requires taking specific steps—willpower alone is inadequate to deal with the various manifestations of bias.

In fact, trying to deal with bias through the illusion of control may actually increase the bias due to “ironic processing” or “ironic rebound.” Hence, trying to minimize bias by willpower makes you think of it more and increases its effect. This is similar to a judge instructing jurors to disregard specific evidence. By doing so, the judge makes the jurors notice this evidence even more.

Such fallacies’ beliefs prevent dealing with biases because they dismiss their powers and existence. We need to acknowledge the impact of biases and understand their sources to take appropriate measures when needed and when possible to combat their effects.

Fallacy	Incorrect Belief
Ethical Issues	It only happens to corrupt and unscrupulous individuals, an issue of morals and personal integrity, a question of personal character.
Bad Apples	It only happens to corrupt and unscrupulous individuals. It is an issue of morals and personal integrity, a question of personal character.
Expert Immunity	Experts are impartial and are not affected because bias does not impact competent experts doing their job with integrity.
Technological Protection	Using technology, instrumentation, automation, or artificial intelligence guarantees protection from human biases.
Blind Spot	Other experts are affected by bias, but not me. I am not biased; it is the other experts who are biased.
Illusion of Control	I am aware that bias impacts me, and therefore, I can control and counter its affect. I can overcome bias by mere willpower.

Six Fallacies that Increase Subjectivity

Mitigating Subjectivity

There are four basic strategies to mitigate the impact of subjectivity.

Data-Driven Decision Making

Utilize data and analytics to inform decisions, reducing reliance on personal opinions and biases.

Establish clear metrics with key performance indicators (KPI), key behavior indicators (KBI), and key risk indicators (KRI) that are aligned with objectives.
Implement robust data collection and analysis systems to gather relevant, high-quality data.
Use data visualization tools to present information in an easily digestible format.
Train employees on data literacy and interpretation to ensure proper use of data insights.
Regularly review and update data sources to maintain relevance and accuracy.

Standardized Processes

Implement standardized processes and procedures to ensure consistency and fairness in decision-making.

Document and formalize decision-making procedures across the organization.
Create standardized templates, checklists, and rubrics for evaluating options and making decisions.
Implement a consistent review and approval process for major decisions.
Regularly audit and update standardized processes to ensure they remain effective and relevant.

Education, Training, and Awareness

Educate and train employees and managers on the importance of objective decision-making and recognizing and minimizing personal biases.

Conduct regular training sessions on cognitive biases and their impact on decision-making.
Provide resources and tools to help employees recognize and mitigate their own biases.
Encourage a culture of open discussion and constructive challenge to promote diverse perspectives.
Implement mentoring programs to share knowledge and best practices for objective decision-making.

Digital Tools

Leverage digital tools and software to automate and streamline processes, reducing the potential for subjective influence. The last two is still more aspiration than reality.

Implement workflow management tools to ensure consistent application of standardized processes.
Use collaboration platforms to facilitate transparent and inclusive decision-making processes.
Adopt decision support systems that use algorithms and machine learning to provide recommendations based on data analysis.
Leverage artificial intelligence and predictive analytics to identify patterns and trends that may not be apparent to human decision-makers.

Compassionate Accountability

Compassionate accountability involves maintaining a balance between showing empathy and understanding toward employees while holding them responsible for their tasks and performance. This approach fosters a supportive yet results-driven work environment.

Key Principles

Clear Expectations: Establishing clear expectations is foundational. Ensure that each team member understands their role, responsibilities, and goals. This clarity fosters a sense of direction and purpose, promoting accountability.

Compassionate Coaching: Provide frequent, low-impact coaching and feedback to help team members overcome challenges and grow. This approach allows leaders to offer support without taking away the team members’ ownership of responsibility.

Psychological Safety: Create an environment where team members feel safe taking risks, admitting mistakes, and learning from them. This fosters a culture of trust and collaboration, ultimately leading to better business outcomes.

Empathy and Understanding: Understand each team member’s unique needs, challenges, and aspirations. Use one-on-one meetings to build rapport and tailor your management approach to accommodate individual differences.

Constructive Feedback: Provide feedback constructively, focusing on growth rather than blame. This promotes a learning mindset and helps employees see mistakes as opportunities for development.

Lead by Example: Demonstrate the values and behaviors you expect from your team. In your actions, model compassion and accountability, showing that these qualities are not mutually exclusive but complementary.

Practical Strategies

Setting Clear Expectations

Communicate Goals and Roles: Clearly communicate goals, roles, and responsibilities to prevent misunderstandings and ensure that everyone knows what is expected of them.
Transparent Communication: Be transparent about the challenges and obstacles the team might face. Work together to brainstorm solutions and anticipate challenges.

Providing Support and Feedback

Regular Check-ins: Conduct regular check-ins to understand your team members’ challenges and provide timely feedback. This helps in addressing issues before they escalate.
Celebrate Efforts and Results: Recognize and celebrate both efforts and results. This helps maintain motivation and reinforce positive behaviors.

Fostering a Collaborative Environment

Encourage Collaboration: Foster a culture of collaboration and support among team members. Encourage them to help each other and share knowledge.
Joint Accountability: Create an environment of joint accountability where team members can rely on each other for help and show care for one another instead of blaming.

Balancing Compassion and Accountability

Empathy as a Foundation: Use empathy to understand your team’s strengths and guide them toward growth. Empathy helps build trust and makes difficult conversations easier.
Accountability with Compassion: Hold team members accountable in a way that demonstrates care and support. This involves being honest about performance issues while providing the necessary support to overcome them.

Continuous Improvement

Reflect and Adapt: Continuously reflect on your approach’s outcomes and adapt as necessary. Seek feedback from your team and be open to making changes that enhance compassion and accountability.

Use of Pronouns

Proper pronoun use is a small but significant step towards building a more inclusive, respectful, and equitable workplace. It helps create a culture where all individuals feel seen, heard, and valued, which is essential for fostering a positive and productive work environment.

Practical Steps to Ensure the Use of Preferred Pronouns at Work

1. Lead by Example

Include Pronouns in Signatures: Encourage employees to add their pronouns to email signatures, LinkedIn profiles, and other digital communication channels.
Introduce with Pronouns: Leaders and managers should model the behavior by introducing themselves with their pronouns in meetings and communications.

2. Use Gender-Neutral Language

Address Groups Inclusively: Use terms like “team,” “folks,” or “everyone” instead of gendered terms like “ladies and gentlemen”.
Inclusive Terms: Replace gender-specific terms such as “maternity leave” with “parental leave” and use “partner” or “spouse” instead of “husband” or “wife”.

3. Provide Education and Training

Regular Training Sessions: Conduct mandatory training on using correct pronouns and inclusive language.
Continuous Learning: Offer ongoing education opportunities rather than one-time sessions to ensure the practice becomes ingrained in the company culture.

4. Create a Supportive Environment

Encourage Voluntary Disclosure: While promoting pronoun sharing, ensure it remains voluntary to avoid pressuring employees who may not be ready to disclose their gender identity.
Normalize Pronoun Sharing: Make sharing pronouns a regular part of introductions and communications to normalize the practice.

5. Address Mistakes Appropriately

Correct and Apologize: If someone uses the wrong pronoun, they should correct themselves, apologize, and try to use the proper pronoun in the future.
Practice Pronouns: Encourage employees to practice using correct pronouns to prevent mistakes and create a more inclusive environment.

6. Implement Policies and Consequences

Anti-Discrimination Policies: Ensure that company policies explicitly prohibit discrimination based on gender identity and expression, including intentional misgendering.
Consequences for Misgendering: Include intentional misgendering and deadnaming in the formal definition of harassment and outline clear consequences for such behavior.

7. Visible Support from Leadership

Senior Leadership Engagement: Ensure senior leaders actively support and participate in pronoun initiatives to demonstrate the company’s commitment to inclusivity.

Build Wonder in the Organization

A sense of wonder significantly enhances critical thinking by fostering curiosity, creativity, and deeper engagement with the subject matter.

Curiosity and Inquiry: Wonder naturally leads to curiosity, prompting individuals to ask questions and seek answers. This inquisitive mindset is a cornerstone of critical thinking, as it drives the exploration of new ideas and the examination of existing knowledge.
Engagement and Motivation: Experiencing awe and wonder can make learning more engaging and enjoyable. This emotional engagement motivates individuals to delve deeper into subjects, enhancing their understanding and retention of information.
Creativity and Imagination: Wonder stimulates the imagination, allowing individuals to think beyond conventional boundaries and explore new possibilities. This creative thinking is essential for problem-solving and innovation. Critical thinking involves analyzing information and synthesizing new ideas, which is facilitated by a sense of wonder.
Empathy and Perspective-Taking: Wonder can also foster empathy by encouraging individuals to see the world from different perspectives. This empathetic understanding is crucial for critical thinking, allowing for a more comprehensive and nuanced analysis of issues.
Mindfulness and Reflection: Engaging with wonder often involves mindfulness and reflection, which are essential for critical thinking. Taking time to contemplate and reflect on experiences allows individuals to process information more thoroughly and develop well-reasoned conclusions. This reflective practice helps shift perspectives and integrate new knowledge.

Photo by Magda Ehlers: https://www.pexels.com/photo/brown-monkey-photo-767197/

Building a sense of wonder in the workplace involves creating an environment that encourages curiosity, creativity, and engagement.

1. Encourage Curiosity and Open-Mindedness

Ask Open-Ended Questions: Encourage open-ended questions that stimulate thinking and discussion to promote a culture where employees feel comfortable asking questions and exploring new ideas.
Vocalize Thoughts: Create an environment where employees are encouraged to share their thoughts and ideas openly, without fear of judgment. This helps in fostering a culture of curiosity and innovation.

2. Foster a Positive and Supportive Environment

Effective Communication: Ensure that communication within the organization is open and transparent. This builds trust and collaboration among team members, essential for a positive work environment.
Recognition and Rewards: Acknowledge and celebrate achievements. This boosts morale and encourages employees to continue exploring and innovating.

3. Create Opportunities for Exploration and Learning

Professional Development: Offer opportunities for continuous learning and professional growth. This can include training sessions, workshops, and access to educational resources.
Encourage Experimentation: Allow employees to experiment with new ideas and projects. The freedom to explore can lead to innovative solutions and a greater sense of wonder.

4. Incorporate Sensory Experiences

Engage the Senses: Create a work environment that stimulates the senses. This can include visual displays and frequent and deliberate time on the front line. Engaging the senses can enhance well-being and foster a sense of wonder.
Mindful Practices: Encourage mindfulness practices such as meditation or nature walks. These activities can help employees stay present and appreciate the beauty and complexity of their surroundings.

5. Promote a Culture of Reflection and Feedback

Reflective Space: Provide spaces where employees can reflect and think deeply about their work. This can be a quiet room or a designated area for contemplation.
Feedback Mechanisms: Implement regular feedback sessions where employees can discuss their experiences and insights. This helps continuous improvement and fosters a culture of learning and wonder.

6. Lead by Example

Leadership Engagement: Leaders should model a sense of wonder by being curious, open-minded, and engaged. When leaders demonstrate these qualities, it sets a tone for the entire organization.
Beginner’s Mindset: Encourage leaders and employees to adopt a beginner’s mindset, approach problems and opportunities with fresh eyes, and be open to new possibilities.

Conducive Culture

Another building block to Quality Culture is conducive culture, which is an environment that promotes employee productivity, satisfaction, and well-being. There is a huge overlap between the concepts of a Just and Conducive Culture.

Physical Comfort and Resources: Ensuring employees have a comfortable physical environment and the necessary resources to perform their tasks effectively.
Open Communication: Encouraging transparent and open communication between employees and management helps build trust and fosters a sense of teamwork.
Recognition and Reward: Regularly acknowledging and rewarding individual contributions can maintain high levels of employee motivation and engagement.
Diversity, Equity, and Inclusion (DEI): Promoting a culture that values diversity, equity, and inclusion can lead to a more respectful and collaborative workplace, enhancing employee morale and productivity.
Work-Life Balance: Supporting employees in achieving a healthy work-life balance through flexible working hours and telecommuting opportunities can increase their engagement and motivation.
Positive Organizational Values: Establishing and operationalizing core values that align with collaboration, learning, and adapting (CLA) can create a supportive and innovative work environment.
Feedback and Development: Regular, constructive feedback and opportunities for professional growth help employees feel valued and supported in their roles.
Team Culture: Promoting teamwork and collective responsibility for outcomes can enhance the organization’s overall performance and success.

A conducive culture fosters innovation, collaboration, and inclusivity, all vital elements of a quality culture.